WP1 has been set the objective of providing the Alliance with an overall scientific and governance structure that will facilitate collaboration, support, and effective supervision among all our partners. Such a clear statement of goals and expected outcomes will ensure the quality and timeliness of deliverables and that the project’s objectives are effectively managed.
- Coordinating all activities, logistics, and tracking and reporting progress;
- Approving the project’s deliverables and the processes they involve;
- Ensuring that mechanisms are put in place for overall contractual, financial, ethical, administrative management, and to resolve conflicts;
- Creating and organizing internal communication channels and tools for disseminating information about successful results (together with WP7);
- Aligning all aspects of the project to ensure that all stakeholders and partners are fully engaged;
- Identifying short-term and long-term sustainability strategies.
AEMPS, Amgen, AP-HP, Barts Health, Bayer, BfArM, Celgene, EAPM, EBMT, EHA, ELN, EORTC, Erasmus MC, ERIC, FisM Onlus, GFM, GMV, Goethe University, GPOH, GRAALL, GRL-SANGER, HHU, HULAFE, IECSCYL-IBSAL, IJC, Janssen, LeukaNET, LMU, LYSA, MediSapiens, MediUni Wien, Menarini, MML, MU, Newcastle University, NICE, Novartis, OPBG, SYNAPSE, Takeda, UCAM, Ulm University, UNIBO, UNITO, University of Helsinki, University of Navarra, University of Rome Tor Vergata, University of York, VHIO, VIB, VUMC.
- Greatly supported and coordinated other WPs interactions, being particularly present at key multidisciplinary tasks such as the definition of outcomes and establishment of a safe data anonymisation procedure.
- Negotiated agreements with over 50 European institutions that have expressed their desire to join HARMONY as Associated Members; this has resulted in the acceptance of 13 new Associated Members in 2018 and the signature of 11 AM data sharing agreements. Additionally, coordinated the data sharing of 6 HARMONY Partners, among which 1 EFPIA member.
- Kept HARMONY’s Ethics Advisory Board and Expert Advisory Panel duly informed on the progress of the project, and implemented their advice in the relevant frameworks.
- Fostered, implemented and dynamized the procedure for the submission and approval on bench-to-bedside research proposals;
- Coordinated the preparation of IMI paperwork: amendments to HARMONY's framework documents (Consortium and Grant Agreements), “Periodic technical report (annual scientific and financial reports) , and deliverables established for 2018.
- Established the Ethics Advisory Board and External Advisory Panel. Reference to the advisors for the development of HARMONY’s “modus operandi” on data privacy and the establishment of ties with other international initiatives;
- Coordinated and aligned on a common terminology: HARMONY and re-use of data;
- Developed a procedure for the submission and approval on bench-to-bedside research proposals;
- Developed of the legal framework for data sharing with Associated members: Associated Members’ Engagement Framework and Associated Members’ Data Sharing Agreement;
- Contacted 55 Associated Members. Positive reply and AMEF signed from 14 organizations. Another 19 organizations on signature process;
- Made agreements with industry partners for sharing published clinical trial data in existing bench-to-bedside projects;
- Coordinated activities, the development of management internal procedures and the adjustment to changes: submitted the first amendment;
- Submitted deliverables to the Innovative Medicine Initiative, funder of the HARMONY Alliance.
WP2 will continue to focus on:
- Continue expanding the HARMONY network by incorporating new Associated Members who are willing to share their data and become involved in research projects.
- Pave the way for more public and pharmaceutical partners to include their data in the HARMONY Platform.
- Foster the submission of new research proposals and shorten the approval process.
- Start discussing HARMONY’s sustainability model beyond IMI funding period.
- Keep bringing together stakeholders in the HMs field in order to speed up the definition of relevant outcomes.